WHO authorizes AstraZeneca COVID-19 vaccine for emergency use
The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval.
UK: Drug major, AstraZeneca, has recently announced that the company's COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65.
The authorisation of COVID-19 Vaccine AstraZeneca manufactured by AstraZeneca, and COVISHIELD manufactured by Serum Institute of India (SII), enables global access to the vaccine during the pandemic.
The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
AstraZeneca and SII will now work with the COVAX Facility to begin supplying the vaccine around the world, with the majority going to low and middle-income countries as quickly as possible. In the first half of 2021, it is hoped that more than 300 million doses of the vaccine will be made available to 145 countries through COVAX, pending supply and operational challenges. These doses will be allocated equitably according to the COVAX Allocation Framework.
Pascal Soriot, Chief Executive Officer, said: "Approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation. This is a huge step towards ensuring global access to our vaccine and helping us fulfil our public health commitment to broad and equitable access at no profit during the pandemic."
Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said: "We have been waiting for this final milestone. I am happy and relieved that with the WHO's EUL we will be able to start the deliveries to African and other low and middle-income countries immediately. Countries with a large population must be protected as soon as possible."
"The company has committed to making its COVID-19 vaccine available to as many countries as possible and at no profit during the pandemic period," AstraZeneca said.
In June 2020, the Company announced a sub-licencing agreement with the SII to manufacture and supply up to one billion doses of the vaccine to low and middle-income countries.
The Company was the first global pharmaceutical company to join COVAX in June 2020. This global mechanism is working to accelerate the development, production and equitable access to new COVID-19 tools across the world for all participating countries, regardless of income level.
AstraZeneca's COVID-19 vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.